Kornimate/medical-research-clean huggingface dataset:
selecting patients who may benefit from immunotherapy by tissue-based biomarkers.

Conditions: Gastric Cancer Patients Received Immunotherapy

Summary: we have established a machine learning model based on effective tiic signature which could select gc patients who may benefit from immunotherapy. the current study aims to enroll 300 gc patients as a validation cohort to vertify the accuracy of tiic signature in predicting immunotherapy efficacy


Eligibility criteria:
inclusion criteria: * having signed informed consent * age:18-80 years old * histologically confirmed gastric adenocarcinoma * unresectable recurrent or metastatic gastric cancer * previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months * measurable disease according to the recist criteria * karnofsky performance status ≥70 * life expectancy of ≥3 month * no prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks * alt and ast\<2.5 times uln (≤5 times uln in patients with liver metastases) * serum albumin level ≥3.0g/dl * serum akp \< 2.5 times uln * serum creatinine \<uln, and ccr \< 60ml/min * bilirubin level \< 1.5 uln * wbc\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, hb\>9g/dl exclusion criteria: * previous systemic therapy for metastatic gastric cancer * surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. * allergic constitution or allergic history to protium biologic product or any investigating agents. * severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ecg findings, cardiac infarction , or retractable hypertension. * pregnancy or lactation period * other previous malignancy within 5 year, except non-melanoma skin cancer * legal incapacity
simultaneous gemcitabine and irreversible electroporation for locally advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the aim of this study was to compare the therapeutic efficacy between simultaneous gemcitabine administration and ire and ire alone for locally advanced pancreatic cancer (lapc)

in the gem- ire group, before the ire ablation started, patients received 1000 mg/m2 gemcitabine hydrochloride \[qilu pharmaceutical (hainan) co., ltd. haikou, china\] intravenously (over approximately 30 min). in the ire group, the ire ablation was performed without gemcitabine intravenous infusion before ire. the aim of this study was to evslusted the overall survival (os), objective response rate (orr) and adverse events after simultaneous therapy.

Eligibility criteria:
inclusion criteria: * radiologic confirmation of unresectable locally advanced pancreatic cancer by at least ct of chest and abdomen * screening must be performed no longer than 2 weeks prior to study inclusion * maximum tumor diameter ≤ 5 cm * histological or cytological confirmation of pancreatic adenocarcinoma; * age ≥ 18 years * ps-classification 0 - 2 * life expectancy of at least 12 weeks * adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion; * hemoglobin level ≥ 115 g/l * platelet count ≥ 100\*109/l * neutrophil count ≥ 2×109/l; * white blood cell count ≥ 4 ×109/l; * alt and ast ≤ 2.5 x uln * serum creatinine ≤ 1.5 x uln or a calculated creatinine clearance ≥ 50 ml/min * prothrombin time or inr \< 1.5 x uln * written informed consent exclusion criteria: * resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team * history of epilepsy * history of cardiac disease: * cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted) * compromised liver function (e.g. signs of portal hypertension, inr \> 1,5 without use of anticoagulants, ascites) * uncontrolled infections (\> grade 2 nci-ctc version 3.0) * pregnant. women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment * allergy to contrast media * any implanted stimulation device * any implanted metal stent/device within the area of ablation that cannot be removed
pharmacokinetic bioequivalence study of nebcinal® 150mg/3ml administered by aeroneb® idehaler® versus tobi® 300mg/5ml administered by pari lc plus® /pulmoaid® in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a genetic disease characterized by mutations in cftr (cystic fibrosis transmembrane conductance regulator) gene. mortality and morbidity are mostly related to the respiratory affection which appears early in neonates. the constant improvement in symptomatic treatments and care strategies allowed cf patients' life expectancy to be increased over the last decades. vital prognostic is related to bronchopulmonary infections. 39% of cf patients under 18 years old and 70% of adult cf patients are chronically infected by pseudomonas aeruginosa. elevated concentrations of tobramycin in broncho secretions, about 1000 times the mic, is obtained by inhaled administration of tobramycin and is active against in-vitro resistant pseudomonas aeruginosa. study hypotheses : regarding literature data and in-vitro studies, the administration of nebcinal® 150mg/3ml administered twice a day by aeroneb® idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as tobi® 300mg/5ml administered twice a day by pari® lc plus® in children and adult patients with cf. primary objective : to compare plasma concentrations after inhalation of nebcinal® 150mg/3ml administered by aeroneb® idehaler pocket® and tobi® 300 mg/5ml administered by pari lc plus®


Eligibility criteria:
inclusion criteria: * adults and children aged 6 years old and more * male or female * patients with cystic fibrosis (positive sudoral test, cl \> 60 mmol/l) * followed in a crcm (cf care centre) * fev1 ≥40% * informed consent collected from adults or parents or legal guardians and children. * affiliation to the national health insurance program (sécurité sociale). exclusion criteria: * renal insufficiency defined by a creatinine clearance level superior to 2 mg/dl * recent pneumothorax, emphysema, punction or recent pleural biopsy, recent haemoptysis superior to 60 ml within 30 days prior to randomization * acute pulmonary exacerbation pathology, according to conference of consensus (2002), evaluated by : * cough increase * sputum increase * decrease in tolerance to effort * loss of weight, lack of appetite * deterioration of respiratory function * medical history of intolerance, toxicity or allergy to tobramycin, hypersensitivity to aminoside

Keywords: cystic fibrosis bioequivalence pharmacokinetic sputum plasma
noninvasive dual-mode stimulation therapy for neurorehabilitation in post-stroke cognitive impairment

Conditions: Post-stroke Cognitive Impairment

Summary: repetitive transcranial magnetic stimulation (rtms) or transcranial direct current stimulation (tdcs) has been used for the modulation of post-stroke cognitive impairment patients' cognitive function by altering the cortical excitability. recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. in this study, simultaneous stimulation using both facilitatory rtms (10hz) and anodal or cathodal tdcs (dual-mode stimulation) over bilateral dorsolateral prefrontal cortices (dlpfcs) was investigated to compare its modulatory effects with single facilitatory rtms stimulation in post-stroke cognitive impairment patients.


Eligibility criteria:
inclusion criteria: * first-ever stroke patients * subacute stage (less than 4 weeks) * who can perform the 2-back verbal and non-verbal working memory task exclusion criteria: * k-mmse score under 9 * major active neurological disease or psychiatric disease * a history of seizure * metallic implants in their brain

Keywords: noninvasive brain stimulation repetitive transcranial magnetic stimulation transcranial direct current stimulation
phase i hepatitis c vaccine trial of virosome-formulated peptides

Conditions: Chronic Hepatitis C

Summary: pevion biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis c virus infection. the vaccine is based on a combination of the pevipro and peviter platforms using synthetic peptide antigens from the hepatitis c virus. generally, a cellular immune response by cytotoxic t-lymphocytes (ctl) seems to be crucial in overcoming a hepatitis c virus infection. in-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper t-cells. pevion biotech's hcv vaccine candidate utilizes this effect inducing specific ctl responses (peviter) together with a supportive helper t cell response (pevipro). this virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.


Eligibility criteria:
inclusion criteria: * healthy volunteers of both sexes * aged between 18 and 45 years * free of obvious health problems * with a bmi between 18.5 and 29.9 are included if they give written informed consent exclusion criteria: * chronic or acute illness * immunosuppression * hcv and/or hbv infection * history of allergic disease * pre-existing immune response against peptide of the vaccines

Keywords: hepatitis c liver disease viral infection virosome vaccine therapeutic vaccine chronic hepatitis c virus infection
comparison of the quantity of distal movement of the upper canine and molar

Conditions: Malocclusion

Summary: the purpose of the study is compare the quantity of distal movement of the upper canine and molar using class ii elastics with and without sliding jig in a period of 3 months

to achieve a class i canine relationship at the end of the alignment and leveling phase, different intraoral devices have been used. these include intermaxillary class ii elastics, which retract the upper and protract the lower arch, generating extrusive forces at the anchorage sites. its upper distalizing action is exerted to the canine bracket and transmitted through the posterior teeth where the upper molar does not receive a direct force. the sliding jig is an auxiliary addition that exerts force to the molar by an elastic hanged in a jig between the lateral and the canine in class ii; such mechanism decreases the vertical adverse effects of the elastics wearing while directing the distalizing force to the molar. a randomized, unblinded, clinical trial comparing 30 units of analysis (hemi arches) in which were placed sliding jig or stand alone elastics were perform.

Eligibility criteria:
inclusion criteria: * class ii dental malocclusion with alignment and leveling phase ended. * root completed not trauma * second molar erupted * third molar absent * dental and periodontal health exclusion criteria: * root uncompleted * dental trauma * dental pathology

Keywords: sliding jig class ii malocclusion distalization mechanics intermaxillary elastics
safety and efficacy of once-daily dosing of foamotic cipro compared to twice-daily dosing of ciloxan ear drops in patients with acute external otitis

Conditions: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis

Summary: the purpose of this study is to assess the safety and efficacy of foam otic cipro (0.3% ciprofloxacin otic foam), used once-daily for 7 days for the treatment of acute diffuse otitis externa, compared to commercial ear drops used twice daily for 7 days.

acute otitis externa (aoe) is defined as a diffuse inflammation of the external ear canal, which may also involve the pinna and/or the tympanic membrane. aoe is one of the most common infections encountered by otolaryngologists, pediatricians and family physicians. diagnosis of aoe requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal inflammation which includes: a) otalgia (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; b) tenderness of the tragus and/or pinna; and c) diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge.

Eligibility criteria:
inclusion criteria: * aged 18 and older eligible to sign by themselves. * have a clinical diagnosis of acute otitis externa based on clinical observation and of presumed bacterial origin. * intact tympanic membrane * unilateral acute otitis externa exclusion criteria: * known allergy or sensitivity to ciprofloxacin or other quinolones. * clinical diagnosis of chronic suppurative otitis media (csom), acute otitis media (aom), involvement of middle ear effusion (mee). * patient has the non intact tympanic membrane. * patient has a serious underlying disease. * patients with known history of immune dysfunction/deficiency and those receiving immunosuppressive therapy. * patients with history of diabetes mellitus. * bilateral acute otitis externa. * patients with more than 80% of the ear canal occluded. * pregnant or lactating patients. * overt fungal acute otitis externa. * local ear canal abnormalities such as abscess, granulation or polyps. * congenital abnormalities of the external auditory canal or obstructive bony exostosis in the treated ear. * mastoid or other suppurative non-infectious ear disorder (e.g. cholesteatoma) in the treated ear. * seborrheic dermatitis or other dermatological conditions of the external auditory canal which would complicate evaluation. * current infection requiring systemic antimicrobial therapy. * current or previous use of topical or oral antibiotics (within 3 days) or long-acting antibiotics (within 7 days). * current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.

Keywords: swimmer's ear ear drops ear foam otic foam ear infection ear pain ear inflammation
antioxidants for prevention of cataracts follow-up study

Conditions: Cataract

Summary: aravind eye hospital and the university of california, san francisco (ucsf) proctor foundation collaborated on the antioxidants for the prevention of cataract study from 1997-2002. (1) in the study, 798 participants aged 35-50 years were enrolled from 5 rural villages, and randomized to thrice weekly antioxidants (vitamin c, 500 mg; beta carotene, 15 mg; and alpha-tocopherol, 400 iu) or placebo. after 5 years of supplementation, there was no significant difference in cataract formation between the antioxidant group and placebo. in this follow-up study, we will return to study villages to determine whether rates of cataract surgery are different in the 2 groups. 1. gritz dc, srinivasan m, smith sd, et al. the antioxidants in prevention of cataracts study: effects of antioxidant supplements on cataract progression in south india. the british journal of ophthalmology 2006;90:847-51.


Eligibility criteria:
inclusion criteria: * participation in previous cataract study exclusion criteria: * refusal to participate
a clinical trial of dermacorder for detecting malignant skin lesions

Conditions: Basal Cell Carcinoma

Summary: the dermacorder measures the electric field in the skin. malignant skin lesions disrupt the skin's normal electric field and this abnormal electric field can be detected by the dermacorder. therefore the investigators are testing the hypothesis that the dermacorder can provide useful data to guide in the diagnosis of skin disease.

the dermacorder is a non-invasive medical device that scans a probe over the skin about 200 microns away from it and detects the electric field in the skin using capacitative coupling. measurements of hundreds of malignant melanomas in mice indicated that these lesions generate an electric field that is easily detected. one previous clinical trial at the va medical center in hampton va indicated an 80% reliability in predicting malignant lesions by their electric field. we have improved the dermacorder over the past two years by enhancing its sensitivity and stability and must now determine if these improvements have improved its ability to detect malignant lesions. if the dermacorder provides a reliable diagnosis of malignant lesions, its use could dramatically reduce the number of biopsies performed and this would significantly improve the quality of life for hundreds of thousands of americans seeking the advice of dermatologists regarding suspicious lesions each year

Eligibility criteria:
inclusion criteria: * study subjects must have had diagnosed at least one benign or malignant skin lesion; * subject is from 18-75 years of age, inclusive; * subject must sign and date all informed consent statements. exclusion criteria: * subject is exhibiting signs of a bacterial or viral infection, including fever; * subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.

Keywords: dermacorder electric field basal cell carcinoma gorlin syndrome
nasal anatomical and pathological variants in patients with antrochoanal polyps

Conditions: Antrochoanal Polyp

Summary: the goal of this observational study is to learn about anatomical and pathological variants in patients with antrochoanal polyps trying to find a key to its pathogenesis participants will have nasal endoscopic examination and ct nose and paranasal sinuses. we will compare patients with antrochoanal polyps and other patients with unilateral sinonasal disease regarding anatomical and pathological variants.

this study was conducted at otolaryngology department, minia university hospital, minia, egypt. the study was approved by the institutional review board at minia university. the study participants were recruited from patients complaining from unilateral sinonasal disease attending outpatient clinic. we selected 40 patients with acps who had the following inclusion criteria: 1-radiologically diagnosed based on ct nose and pns. 2-histopathologically diagnosed as acp. the radiological diagnosis is based on seeing low attenuated soft tissue mass filling the maxillary antrum and extending through the middle meatus into the nasal cavity and directs towards the post nasal opening. we excluded: 1- patients with history of maxillofacial trauma. 2- patients who had previous nasal surgery. to be more objective, a control group of 40 patients who had unilateral sinonasal disease other than acp was formed. we assessed multislice computed tomography (ct) nose and paranasal sinus images by toshiba aquilion ct scanner. axial and coronal 250mm cuts were obtained. both study and control groups were compared regarding anatomical and pathological variations in the nose. these variants include: deviated nasal septum, concha bullosa, paradoxical middle turbinate and uncinate process insertion (to lamina papyrecea or roof of ethmoid or middle turbinate). we also compare between them according to presence of retention cyst in ct in contralateral side in the cases with deviated nasal septum, the septal deviation was seen if it is towards the side of the lesion or towards the opposite side according to its convexity. we also evaluate the sclerosis on thickening of the bony wall of the para nasal sinus as an indication of chronic inflammation. spss 24.0 program was used for statistical analysis. averages and standard deviations were calculated. the mann-whitney and chi square tests were used for comparisons between the groups. the pearson correlation tests was used to evaluate correlations. statistical significance was set at ≤ 0.05.

Eligibility criteria:
inclusion criteria: 1. radiologically diagnosed based on ct nose and pns. 2. histopathologically diagnosed as acp. exclusion criteria: 1. patients with history of maxillofacial trauma. 2. patients who had previous nasal surgery.
effect of doxycycline in levodopa treated parkinson's disease patients

Conditions: Parkinson Disease

Summary: this study is a randomized, double-blind, placebo-controlled trial. the objective of the study is to assess the effect of doxycycline in levodopa treated parkinson's disease patients regarding motor performance and cognitive functions. parkinson's disease patients on levodopa medications will be assigned to receive doxycycline 50mg twice daily or placebo over 8 weeks. the motor and cognitive symptoms of parkinson's disease will be assessed after 4 weeks and 8 weeks follow up.

parkinson's disease is a progressive neurodegenerative disorder that is caused by degeneration of dopaminergic neuron in the substantia nigra. most commonly used drug, levodopa can improve the dopamine level in brain but cannot give neuroprotection and also induces motor fluctuations and dyskinesia in many patients. doxycycline has been shown anti-inflammatory and neuroprotective effects against parkinson's disease on animal model. it also reduced levodopa induced dyskinesia without compromising the motor benefits of levodopa. therefore, the present study is to attempt to improve the sign symptoms of parkinson's disease by giving doxycycline along with levodopa. this study is a randomized, double-blind, placebo-controlled trial and conducting at department of pharmacology, bsmmu in collaboration with department of neurology, bsmmu. a total of 60 patients suffering from parkinson's disease is selected according to inclusion and exclusion criteria. the diagnosis of the patients suffering from parkinson's disease will be performed by a neurologist at movement disorder clinic of department of neurology, bsmmu. patients will undergo mds-unified parkinson's disease rating scale (mds-updrs) to assess the severity of the disease. the patients will be randomly allocated into two arms: control and intervention. patients in intervention arm consisted of 30 patients who will receive levodopa plus doxycycline orally for 8 weeks. on the other hand, control arm consisted of 30 patients who will receive levodopa plus placebo for 8 weeks. the severity of parkinson's disease will be assessed after 4 weeks and 8 weeks follow up.

Eligibility criteria:
inclusion criteria: * diagnosed parkinson's disease patient taking levodopa * age: more than 18 years * sex: all exclusion criteria: * secondary causes of parkinsonism * atypical parkinsonian syndromes * prior stereotaxic surgery for parkinson's disease * known hypersensitivity to doxycycline * pregnancy and lactation * suffering from active malignancy

Keywords: "parkinson's disease" "doxycycline"
penile prosthesis in patients with erectile dysfunction

Conditions: Erectile Dysfunction

Summary: erectile dysfunction (ed) is defined as the persistent inability to attain and or maintain an erection sufficient to permit satisfactory sexual performance

in the literature, well- designed studies evaluating safety and efficacy of inflatable penile prosthesis (ipp) is lacking. so, this series aimed at investigating this prospectively.

Eligibility criteria:
inclusion criteria: * patients complaining of ed with contraindication or failure of medical treatment exclusion criteria: * patients lacking manual dexterity or mental abilities necessary to operate the pump * general contraindications as uncorrectable bleeding tendency